Analyte collection and detection devices

Abstract

A system for collecting biological samples, such as fecal specimens, and testing such samples for the presence of an analyte is disclosed. The system comprises a sample collection device that includes a removably secured tab for retaining and transferring a portion of the sample to be tested to the test device. The tab is preferably configured so that it can be received in the test device in only a pre-selected orientation so as to put the portion of the tab carrying the sample in communication with a chromatographic material in the test device.

1. A sample collection device comprising:
 (a) a body having first and second opposed surfaces, wherein the first opposed surface is substantially planar; 
 (b) sample tab removably secured to the first opposed surface, comprising a handle having a proximal end and a distal end; 
 (c) an absorbent material for receiving a fecal sample, the absorbent material being attached to the distal end of the sample tab; and 
 (d) a flap connected to the first opposed surface, the flap comprising a proximal edge covering at least a portion of the absorbent material of the sample tab when the sample tab is removably secured to the first opposed surface; 
 wherein the proximal edge of the flap is adapted to extend away from the first opposed surface when the first opposed surface is flexed convexly to provide clearance for the absorbent material when the sample tab is removed from the first opposed surface. 
 
     
     
       2. The sample collection device of  claim 1 , wherein the first opposed surface of the body comprises a piece of rigid material, and wherein the sample tab comprises a sample tab backing formed by perforations in the piece of rigid material, the sample tab backing comprising the handle. 
     
     
       3. The sample collection device of  claim 1 , wherein the flap is formed in the first opposed surface of the body. 
     
     
       4. The sample collection device of  claim 1 , wherein the absorbent material is impregnated with a band of moisture barrier material separating a sample collection end of the absorbent material from the remainder of the absorbent material. 
     
     
       5. The sample collection device of  claim 1 , wherein a portion of the absorbent material extends beyond the distal end of the handle. 
     
     
       6. The sample collection device of  claim 1 , wherein the second opposed surface comprises a window in liquid communication with the absorbent material. 
     
     
       7. The sample collection device of  claim 6 , wherein the window includes a filter material which allows liquid to flow through the filter material but which inhibits the flow of solids. 
     
     
       8. The sample collection device of  claim 6 , further including a cover member adapted to cover the window of the second opposed surface. 
     
     
       9. The sample collection device of  claim 1 , wherein the body of the sample collection device is formed from a cellulose-based material resistant to moisture. 
     
     
       10. A method of collecting a fecal sample, comprising:
 (a) providing a sample collection device comprising:
 (i) a rigid body having a substantially planar surface; 
 (ii) a sample tab removably secured to the substantially planar surface of the rigid body, the sample tab comprising a handle having a proximal end and a distal end attached to an absorbent material which carries a fecal sample; and 
 (iii) a flap having a distal end attached to the substantially planar surface of the rigid body and a proximal end abutting the distal end of the handle; 
 
 (b) flexing the rigid body, thereby detaching the proximal end of the handle from the substantially planar surface and causing the proximal end of the flap to extend away from the substantially planar surface; and 
 (c) pulling the handle away from the flap. 
 
     
     
       11. A device for the collection and transportation of a fecal sample comprising:
 (a) a substantially planar body having front and back opposed surfaces, wherein said front surface includes a sample collection area configured to receive the sample; 
 (b) a sample collection member removably secured to the back surface of the substantially planar body, wherein a region of the sample collection member is in fluid communication with the sample collection area, wherein said sample collection member is configured to remove a portion of the sample received by the sample collection area when separated from the back surface of the substantially planar body; and 
 (c) a flap attached to the back surface of the substantially planar body, wherein said flap includes a proximal edge that covers the sample collection area and covers at least a portion of the sample collection member when the sample collection member is removably secured to the back surface. 
 
     
     
       12. The device of  claim 11 , wherein the removably secured sample collection member comprises a handle end configured to extend away from the back surface of the substantially planar body when the substantially planar body is flexed, thereby facilitating the detachment of the sample collection member from the back surface of the substantially planar body. 
     
     
       13. The device of  claim 11 , wherein the flap is configured to extend away from the back surface of the substantially planar body when the sample collection member is detached from the substantially planar body. 
     
     
       14. The device of  claim 11 , wherein the sample collection member is asymmetrical, wherein the sample collection member is sized and shaped to be received in a pre-selected orientation in a test device. 
     
     
       15. The device of  claim 11 , further comprising a filter material interposed between the sample collection area and the sample collection member, wherein the filter material allows the flow of liquid and analyte of interest through the filter material to the sample collection member but inhibits the flow of solids. 
     
     
       16. The device of  claim 11 , further comprising a cover member attached to the front surface, the cover member adapted to cover the sample collection area. 
     
     
       17. The device of  claim 11 , wherein the sample collection member comprises an area of predetermined size that is in fluid communication with the fecal sample, to remove a substantially consistent quantity of the fecal sample received by the sample collection area when separated from the back surface of the substantially planar body.